MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE

Catalog Number 302561

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger rod for the bd plastipak¿ syringes was incorrectly positioned.The following was translated from spanish to english: failures are reported during the use of the bd plastipak syringe, a poor fit of the plunger with the syringe is evident, favoring the entry of air, the formation of bubbles and movement of the rubber of the plunger when it is used.

Event Description

No additional information received.Failures are reported during the use of the bd plastipak syringe code 1000005047 desec syringe.Without needle 10ml 302561 bd, a poor fit of the plunger with the syringe is evident, favoring the entry of air, the formation of bubbles and movement of the rubber of the plunger when it is used.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, it was observed that the stopper was incorrectly assembled to the plunger, distorted against the barrel wall.A device history review was performed for lot 3038490, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the teams investigation, possible root cause is associated with improper alignment of the plunger/stopper to the barrel during assembly.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17712354
• MDR Text Key: 322980047
• Report Number: 9614033-2023-00092
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302561
• Device Lot Number: 3038490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1